DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/15/2022, 10/13/2023, and 7/26/2024 are being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
induction device first appearing in claim 80 (corresponding structure described in applicant’s original specification as electromagnetic field generator with coil, or as described in [0016])
control unit first appearing in claim 80 (corresponding structure described in applicant’s original specification as laptop computer, desktop computer, tablet, smartphone, cloud system, as described in [0022]-[0023])
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 85, 86, 88, 89, 98 and 105 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 85 recites the term “repetition rate” in line 18. It is not clear if this is a new instance or refers to the repetition rate mentioned in line 2 of claim 84.
Claim 86 recites the limitation "the blood" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 89 recites the term “tidal breath” in line 2. It is not clear if this is a new instance or refers to the repetition rate mentioned in lines 1-2 of claim 87.
Claims 88 and 105 are unclear. The claim appears to recite a limitation to produce a particular result. However, this is unclear as one cannot determine the process for the adjustments that have to be performed to obtain the claimed result.
Claim 98 recites the limitation "the day" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 80, 82, 83, 84, 86-89, 92, 93, 95, 96, 98, 101, 102, 105 and 107 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0367127 (Meyyappan et al., hereinafter Meyyappan).
In regards to claims 80, 92, 93, and 107, Meyyappan discloses a diaphragm paving device (title and abstract; see figures 1, 4, and 15; paragraphs 106-196) that includes the following components:
an induction device (28-electrodes) configured to generate a spatial field having a targeted shape (electrical stimulation would have an electrical and magnetic field that would have a shape; paragraphs 112-183); and
a control unit (controller - 60) in communication with the induction device and configured to control the induction device to generate the spatial field (paragraphs 141-148 and 174),
wherein the induction device (electrodes - 28) is configured to be positioned at a human or animal patient such that, for activating a diaphragm of the patient, a Phrenic nerve of the patient is stimulable by the spatial field generated by the induction device (see figures 1, 2, 3A, 3B; paragraphs 107-132, 162-164, 167, 172, and 182), and
the control unit is configured to receive ventilation data about a ventilation of the patient, by being connectable to a ventilation machine (element 32) to receive the ventilation data about the ventilation of the patient (paragraphs 127, 143, 156, 172, 176-185),
the control unit is configured to evaluate the ventilation data and to operate the induction device in accordance with the evaluated ventilation data (paragraphs 127, 143, 156, 172, 176-185), and
the control unit is configured to operate the induction device to induce a breathing cycle in the patient or to induce a deep breath in the patient (paragraphs 112, 122-127, 133, 167, 193; life-sustaining mode requires the inducing a breathing cycle).
As seen in figures 1-4, and 7 the claimed induction device is obtained and positioned at a human patient that is ventilated (patient has ventilation tubes connected to a ventilator in figure 1). Paragraphs 107-183 describe the operation of the device for stimulating of the Phrenic nerve of the patient by the spatial field, thus meeting the limitations of claim 92 and 93.
In regards to claim 82, Meyyappan discloses the limitations of claim 80. Meyyappan further shows the presence of
a ventilation machine having a conduit interface configured to be connected to the respiratory system of the patient (ventilation tubes (not labeled) in figure 1 that flow from the ventilator to the breath sensor and to the patient);
an air flow generator configured to deliver air through the conduit interface into the respiratory system of the patient (a ventilator (32)); and
an interface unit configured to provide the ventilation data (breath sensor - 50).
In regards to claims 83, 84, 95, and 96, Meyyappan discloses the limitations of claims 80 and 92. In addition, Meyyappan states paragraphs 112, 103-135, 140, 152, 157, and 179, that the control unit (60) in the stimulator (24) is configured to operate the induction device at a repetition rate for a stimulation duration matched to a specific treatment of the patient, wherein the control unit is configured to define the stimulation duration (physician determines duration based on treatment) or repetition rate (repeating pattern amounts based on strategy being used– paragraphs 130 and 153).
In regards to claim 86 and 102, Meyyappan discloses the limitations of claims 80 and 92. In addition, Meyyappan states in paragraphs (124) the following:
wherein the control unit is configured to operate the induction device to induce a breathing cycle in the patient or to induce a deep breath in the patient (paragraphs 112, 122-127, 133, 167, 193; life-sustaining mode requires the inducing a breathing cycle),
wherein the ventilation arrangement comprises a sensor unit (sensors 48) to sense an oxygen level in the blood of the patient or a carbon dioxide level in the blood of the patient (paragraph 124), the control unit being in communication with the sensor unit, and the control unit being configured to operate the induction device when sensed oxygen level or the sensed carbon dioxide level bypasses a predefined threshold (paragraph 124; usage of feedback control of stimulation suggests operation of induction device based on predefined threshold).
In regards to claims 87 and 89, Meyyappan discloses the limitations of claim 80. Meyyappan states in paragraphs 124-125 the usage of sensors that measure tidal volume (tidal breath sensors) as part of a feedback control mechanism for the stimulation, which adjusts operation of the induction device based on the sensor readings (paragraphs 124-125, 156-159, and 176; claim 59).
In regards to claims 88 and 105, Meyyappan discloses the limitations of claims 80 and 92. Meyyappan discloses adjusting field intensity (amplitude) and duration based on treatment parameters (paragraph 113 – feedback adjustment of stimulation amplitude and duration). Due to the present 112 issues of the claim Meyyappan would meet the limitations of the claims.
In addition, the limitations appear to be directed to an intended result of a process step or an intended use of a device. First, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Second, wherein clauses in method claims are not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04).
In regards to claim 90, Meyappan discloses the limitations of claim 80. Meyyappan further discloses the use of sensors that monitor electromyographic activity or chest wall acceleration (paragraph 124). These would be ventilation data that includes diaphragm contraction and would be connected by diaphragm contraction sensors. The use of the feedback control of stimulation mentioned in paragraph 124 makes the control unit configured to re-adjust operation of the induction device in accordance with diaphragm contraction of the patient.
In regards to claim 98, Meyyappan discloses the limitations of claim 92. Meyyappan also discloses the use of the induction device for repeated stimulation in regular intervals throughout the day (paragraphs 153 – activation of induction device at regular time blocks)
In regards to claim 101, Meyyappan discloses the limitations of claim 92. In addition, the limitations presently being claimed are further limitations of the intended use of the method from claim 92. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 81 and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0367127 (Meyyappan et al., hereinafter Meyyappan) as applied to claims 80 and 92 above, and further in view of US 2011/0046432 (Simon et al., hereinafter Simon).
In regards to claims 81 and 94, Meyyappan discloses the limitations of claims 80 and 92. However Meyyappan does not show that the induction device has an electromagnetic field generator with a coil design. In a related area, Simon discloses a nerve stimulation device (title and abstract). Paragraphs 47-48 disclose the use of magnetic coil stimulator to provide an electric field to tissue in a non-invasive manner to a patient. Paragraph 141 describes delivering the stimulation on the surface of a neck of the patient. Paragraph 105 describes how the phrenic nerve can be stimulated with a magnetic stimulation device. Thus, it would have been obvious to one of ordinary in the art before the filing date of the claimed invention to modify the device and method of Meyyappan to have the induction device be an electromagnetic field generator with a coil design as taught by Simon in order to allow for non-invasive stimulation of nerve tissues.
Allowable Subject Matter
Claim 85 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 91, 97, 99-100, 103, 104, and 106 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
In regards to claims 85, 97, 99, 100, and 103 the prior art does not teach or suggest a method or device that implements a method, with the claimed specific treatments with specific stimulation durations and repetition rates.
In regards to claim 104, the prior art does not teach or suggest a method or device that implements a method, with the claimed specific treatment having repetition rates that change at night and day and where the induction device is operated to stimulate the Phrenic nerve of the patient superimposed in a target rhythm not being synchronous with spontaneous breath of the patient.
In regards to claims 91 and 106, the prior art of record does not teach or suggest a method or device that implements a method, that includes the step of operating the induction by providing trains of the generated spatial field, wherein each train comprises an increase of an intensity of the spatial training field ending at a target intensity of the spatial field.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791